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Odyssey to conduct phase IV study of paromomycin IM injection in India
K R Unnikrishnan, Mumbai | Saturday, October 13, 2007, 08:00 Hrs  [IST]

Odyssey Research, a US-based leading global independent clinical trial management organization, is set to conduct phase IV study for Paromomycin IM injection in Bihar region. The molecule is developed by the Institute of OneWorld Health (iOWH), a US-based non-profit pharmaceutical company.

In an email reply to Chronicle Pharmabiz, Zahra Raney, director of international business development, Odyssey Research, said: "We currently have established operations in India, with an excellent and well-qualified staff, and are eager to rapidly expand our presence in India. We have well-established presence across north India, headquartered in Delhi with another office in Patna. The company's investigator network includes physicians in the capital region - Lucknow, Kanpur, Agra, Jaipur, Patna and Varanasi".

The CRO market in India is in a high growth phase. Under increasing pressure to cut costs and accelerate the clinical development process, biotech and pharma companies are looking to India as an ideal site to conduct clinical trials. Lower infrastructure and labour costs, English-speaking doctors, and an abundant and genetically diverse population of over one billion people make India an attractive destination for clinical studies. In addition, the Government of India has demonstrated a commitment to developing a world-class environment for clinical research, by making rapid advancements in developing its regulatory infrastructure and intellectual property legislation.

"We also have operations in several cities in Argentina - Cordoba, Buenos Aires, Rosario, Mendoza, and if there is a specific request for clinical trials in other cities, we are in a position to increase capacity accordingly. In addition, we are currently developing capabilities in Beijing, China", Raney said.

Odyssey Research has domain expertise in visceral leishmaniasis (VL) and infectious diseases, and is working closely with the Institute of OneWorld Health (iOWH), which develops drugs for people with neglected diseases in the developing world, to support its phase IV study of Paromomycin Intramuscular (IM) injection for the treatment of visceral leishmaniasis (VL) in Bihar. With approximately 500,000 new cases occurring annually, visceral leishmaniasis, also known as kala-azar or black fever, is the world's second most deadly parasitic disease following malaria. The Indian subcontinent carries 70 per cent of all estimated new VL cases per year worldwide, with India alone carrying 50 per cent of all new cases. The most affected state in India is Bihar, but VL is also endemic in the states of Jharkhand, West Bengal, and Uttar Pradesh.

Odyssey's mission is to adhere to a teamwork model that fosters creativity and provides the highest level of ethical standards and quality results to patients and customers in a timely manner. The company utilises a worldwide network of over 1000 independent physician investigators. Odyssey Research has operations in 11 United States and international operations in India, China, and Latin America. Odyssey has a team of highly qualified and experienced staff with a history of managing over 600 clinical trials. Odyssey continues to aspire to be recognized as a global resource team for clinical trial management with a clear focus on quality, integrity, and overall satisfaction.

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